Product Development

End-to-end services, tailored solutions

At Seisa, we offer completely customized solutions. We leave the choices up to you; we bring our team of experts and engineers to any stage of the process where you need support.

Product Design and Development

Our engineers take your idea from concept to completion, incorporating the most sophisticated techniques in the field to meet your objectives. Our deliverables include a device history file (DHF) with product requirements, specifications, risk analysis, verification and validation, regulatory submission and design transfer.

510K Generation

Seisa creates and registers your products, handling documentation, submission to the FDA, and support through reviews.

Prototyping

With 3-D printers, rapid mold generation, and an in-house machine shop, Seisa can produce samples quickly and efficiently from a variety of materials for rigorous and reliable testing.

Process and Tooling Design

We design the assembly process, including material selection, tooling, and fixture development, to optimize for manufacturability and efficiency.

New Product Introduction

Upon design completion, we move your device into production, performing process validation, acquiring materials, and scaling up for volume manufacturing.

Testing and Sterilization

Prototypes can be subjected to dimensional analysis, surface coefficient of friction, burst, simulated use and other assessments in our laboratories. Our network includes sterilization management services, bringing your product from prototype to fully functional.

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